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Document Control
Document Control Regulatory Affairs is an exciting career that requires a dynamic individual capable of handling a multitude of job tasks. Finding a position in Document Control is easy at HireLifeScience.com. We offer excellent job opportunities across the United States and have simplified the hiring process. By clicking on the job title that matches your qualifications you can apply directly to the hiring company. Whether you are embarking on a new career or looking for an advanced position HireLifeScience.com has the right Document Control career for you!
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Senior Clinical Scientist

CSL Behring - King of Prussia, PA

Requirements: Ph.D or MS in life sciences with some previous experience in clinical research or BS with at least 3 years of clinical development experience.  The ability to work cross-functionally is essential.    Excellent communication skills, oral and written, are required.  Strong knowledge of clinical research and the drug development process required. Proven ability to work independentl...more

From CSL Behring - 2/19/2018 6:37:30 AM

Regulatory Information Manager

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Essential Requirements •Minimum 1 year hands-on experience with tracking of regulatory information. •University degree or equivalent experience in life sciences or technical field. •Ability to provide global expertise on requirements for tracking of regulatory submissions and approvals. •Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulat...more

From AstraZeneca Pharmaceuticals - 2/15/2018 5:46:03 AM

Document Coordination Entry

Covance, Inc. a division of LabCorp® - Madison, WI

Education/Qualifications - Bachelor of Science (BS) degree in science or related field a plus; experience may be substituted for education - Ability to learn/utilize word processing software, database, spreadsheet, and specialized software - Excellent communication and interpersonal skills - Excellent attention to detail - Ability to prioritize, organize, and manage time Exp...more

From Covance, Inc. a division of LabCorp® - 2/13/2018 5:47:27 AM

Sr. Compliance Auditor

Catalent Pharma Solutions - Woodstock, IL

Job Description •Manages, leads, and conducts audits (customer, external, and internal).  Includes risk assessments, scheduling, preparing documents prior to the audit, creating PRs in TrackWise and managing audit during execution, and closure •Lead preparations for planned Health Authority Inspections.  •Lead of site Supplier Review Board •Support and implement Central Supplier Quality ...more

From Catalent Pharma Solutions - 2/12/2018 5:48:06 AM

Documentation Specialist/QC Support (NCI)

Leidos Biomedical Research, Inc. - FREDERICK, MD

PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: - College entry level math skills - Strong oral and written communication skills - Experience in quality assurance or control for technical documents, or similar - Knowledge of File Maker Pro, Study Log, Freezerworks, or similar Expected Competencies: - Strong multitaski...more

From Leidos Biomedical Research, Inc. - 2/9/2018 5:53:23 AM

Quality Assurance Manager

Catalent Pharma Solutions - Woodstock, IL

The Role •Define and manage the training, education, and development of the employees at the site, both directly and through staff members •Complete comprehensive review and assessment of Quality documents associated with the production and packaging of Blow/Fill/Seal (BFS) products for adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) •Coordinat...more

From Catalent Pharma Solutions - 1/25/2018 5:46:10 AM

DHR Specialist - 2nd shift

Novartis Pharmaceuticals - Sinking Spring, PA

Minimum requirements High school diploma or equivalent. English 2 years' experience in a manufacturing or quality environment Knowledge, Skills and Abilities: Good interpersonal and communication skills, proven organizational skills and strong attention to detail

From Novartis Pharmaceuticals - 1/25/2018 5:44:40 AM

Sr. Manager, Clinical Document Control and Training

Dynavax - Berkeley, CA

Qualifications Bachelor’s degree with 8+ years’ experience with clinical operations, clinical documents, and SOPs, or equivalent work experience and at least 3 years’ management experience. An effective manager who will work proactively to drive results. Experience in developing SOPs and administering training is a must. Knowledge and experience in current eTMF practices and systems is a must ...more

From Dynavax - 1/24/2018 9:57:04 AM

QC Analyst or Senior Associate (3/12 Shift = Sat - Mon, 6 AM - 6 PM)

Catalent Pharma Solutions - Madison, WI

The Role (daily responsibilities) • Develop a plan and execute laboratory work, plan/schedule independently using customer milestones and business objectives. • Author technical documents such as protocols, SOPs, reports and COAs. • Perform parallel review of laboratory documentation, review technical documents for accuracy, thoroughness and regulatory compliance. • Train, coach and mento...more

From Catalent Pharma Solutions - 1/8/2018 5:43:36 AM

Senior Director, Quality Assurance

Catalent Pharma Solutions - Woodstock, IL

The Role •Develop and implement Site Quality Plan, Quality Unit objectives and related procedures. •Maintain and enhance an effective Quality Management System (QMS) •Interface with all other departments to ensure compliance with cGLP/cGMP. •Monitor site compliance to FDA, EU and all other applicable requirements. •Establish a process to review and Implements site procedures in alignment w...more

From Catalent Pharma Solutions - 12/6/2017 5:44:48 AM

Associate Director, Submission Enablement

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Main Duties and Responsibilities As the Associate Director of Submission Enablement you will provide guidance and expertise to the submission and document publishing enablement teams, which includes business administration of submission management systems, subject matter experts and business processes that govern the compilation, publishing, submission and archival of regulatory documents and su...more

From AstraZeneca Pharmaceuticals - 9/28/2017 5:43:25 AM

Sr. Associate/Manager, Regulatory Affairs

Sun Pharma - Hawthorne, NY

• BA/BS and science where pharmacy related field. Position to be commiserated with education and pharmaceutical industry experience • Regulatory affairs certification is desirable • Minimum 5 to 7 years regulatory experience in submissions to FDA in the generic pharmaceutical industry • Strong background in eCTD and preferably in labeling as well. • Experience in OTC monograph is p...more

From Sun Pharma - 9/11/2017 5:44:05 AM
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